Very Low Birth Weight InfantNCT06555315
Pilot Trial Investigating Every Other Day Dosing of Oral Iron in Premature Infants (IQONic)
A study testing 6 mg/kg of oral iron as ferrous sulfate administered every other day. and 6 mg/kg of oral iron as ferrous sulfate administered every day. in people with Very Low Birth Weight Infant and Premature Infants, run by CHRISTUS Health at 1 site in United States.
Trial summary
Study focuses on determining if daily versus every-other-day (EOD) oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks post-menstrual age in premature neonates Read more about this study
- Who is it for?
- Ages 26 to 32 weeksHealthy volunteers can take part
- Conditions the study is for
- Very Low Birth Weight Infant, Premature Infants, Anemia of Prematurity
- What is being tested?
- 6 mg/kg of oral iron as ferrous sulfate administered every other day. and 6 mg/kg of oral iron as ferrous sulfate administered every day.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 28 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children (Minor < 18 years of age)
- Neonates
- Hospitalized
- Premature infants who are on full enteral feeds and are started on oral iron
- Premature infants who completed 26 0/7 to 32 6/7 weeks' gestation at birth
Who cannot join
- Infants with known congenital anomalies or chromosomal abnormalities (such as Trisomy 18 or Trisomy 21), conditions that affect iron metabolism (such as thalassemia or hemochromatosis), bleeding disorders or coagulopathy, and received iron parenterally prior to randomization
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
CHRISTUS Children's
San Antonio, Texas, 78207
Rosario Ocampo, 210-639-3157, rosario.ocampo@christushealth.org
Richelle Homo, MD
About this study
Official title: Pilot Non-inferiority Study Investigating Daily Versus Every Other Day Dosing of Oral Iron in Premature Infants.
Study focuses on determining if daily versus every-other-day (EOD) oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks post-menstrual age in premature neonates
Read the detailed description
Iron is an important component of hemoglobin, and an essential part of erythropoiesis. It is also a necessary micronutrient for rapidly proliferating and differentiating cells and tissues especially in the brain. Iron deficiency in infancy has been associated with anemia and impaired neurodevelopmental outcomes that extend into childhood. Premature infants are at highest risk for iron deficiency because they are deprived of the iron accretion that occurs in the third trimester of pregnancy, are born with lower iron stores compared to their term counterparts, and have increased utilization and depletion of iron stores with their rapid growth rate.
In older populations, EOD iron supplementation is as effective as daily iron supplementation in the treatment of iron deficiency anemia, with studies revealing significantly fewer gastrointestinal side effects in those who are on EOD iron. Adults regulate their iron status through a feedback pathway involving hepcidin whereby iron-sufficient individuals will have upregulated hepcidin, which leads to decreased iron absorption and availability. Recent studies have revealed that pediatric patients and premature neonates regulate iron absorption through hepcidin in a similar fashion. Though the regulation of iron status through hepcidin has been studied in extremely premature neonates, the clinical effect of EOD dosing of iron has not yet been examined in this population.
This is a non-inferiority, blinded, randomized control trial designed to investigate if EOD iron is comparable to daily iron dosing in achieving iron replete status by reticulocyte hemoglobin measurements in premature infants.
- Conditions
- Very Low Birth Weight Infant, Premature Infants, Anemia of Prematurity, Iron Deficiency, Anaemia in Children, Extremely Low Birth Weight
- Being tested
- 6 mg/kg of oral iron as ferrous sulfate administered every other day., 6 mg/kg of oral iron as ferrous sulfate administered every day.
- Keywords
- Premature infants, Iron, anemia of prematurity, iron deficiency
- Medical subject headings
- Premature Birth, Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 mg/kg of oral iron as ferrous sulfate administered every other day.Dietary supplement
6mg/kg of oral iron as ferrous sulfate administered every other day instead of 6 mg/kg of oral iron daily supplementation.
6 mg/kg of oral iron as ferrous sulfate administered every day.Dietary supplement
6 mg/kg of oral iron as daily ferrous sulfate instead of 6mg/kg of oral iron supplementation administered every other day.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | After the infant achieves full enteral feeds, the infant is started on 6 mg/kg of oral iron daily supplementation. The dose of 6 mg/kg of enteral iron was chosen based on the aforementioned recommendations with evidence of its safety, while minimizing the need to increase the enteral iron dosage if an infant were to be started on ESAs where a dose of 6 mg/kg of enteral iron supplementation is the standard practice. Phlebotomy to obtain a complete blood count, reticulocyte count, and reticulocyte hemoglobin count is pursued the Monday after starting iron supplementation and every 2 weeks thereafter to weeks to monitor hematocrit or hemoglobin levels and iron status. Receives: Dietary Supplement: 6 mg/kg of oral iron as ferrous sulfate administered every day. |
| Intervention Group | Experimental | After the infant achieves full enteral feeds, the infant is started on 6mg/kg of oral iron supplementation administered every other day. The dose of 6 mg/kg of enteral iron was chosen based on the aforementioned recommendations with evidence of its safety, while minimizing the need to increase the enteral iron dosage if an infant were to be started on ESAs where a dose of 6 mg/kg of enteral iron supplementation is the standard practice. Phlebotomy to obtain a complete blood count, reticulocyte count, and reticulocyte hemoglobin count is pursued the Monday after starting iron supplementation and every 2 weeks thereafter to weeks to monitor hematocrit or hemoglobin levels and iron status. Receives: Dietary Supplement: 6 mg/kg of oral iron as ferrous sulfate administered every other day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if daily versus EOD oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks PMA.
The iron replete status will be measured by reticulocyte hemoglobin (Ret-Hb) between EOD and daily iron supplementation.
Measured: 1 Week-36 Weeks
Secondary outcomes (6)
Characterize Ret-Hb levels in preterm infants.
Laboratory data obtained from a query of the medical records will be used to characterize reticulocyte-hemoglobin (Ret-Hb) levels. The units used for Ret-Hb is "pg" or picograms.
Measured: 12-24 Months
Identify the number of blood transfusions received between enrollment and 36 weeks' PMA between two groups.
Blood bank data obtained from a query of the medical records will be used to identify the number of blood transfusions received by each study participant.
Measured: 12-24 Months
Determine prevalence of bronchopulmonary dysplasia between two groups.
A chart review of medical records will be used to identify which participants developed a diagnosis of bronchopulmonary dysplasia (BPD), clinically defined as the study participant requiring supplemental oxygen and/or respiratory support either at 28 days postnatal age or 36 weeks' postmenstrual age. The severity of BPD will be defined as that outlined by the 2019 Jensen guidelines.
Measured: 12-24 Months
Identify the number of subjects with sepsis between two groups.
Microbiology data obtained from a query of medical records will be used to identify which participants developed blood, urine, or cerebrospinal fluid culture positive sepsis.
Measured: 12-24 Months
Identify the number with necrotizing enterocolitis (NEC)/gastrointestinal perforations between two groups.
A chart review of medical records will be used to identify which participants developed necrotizing enterocolitis and/or gastrointestinal perforations.
Measured: 12-24 Months
Characterize growth between two groups.
A query of medical records will be conducted to identify weight (grams), height (centimeters), and head circumference (centimeters) percentiles and velocity for the infants at birth up until 36 weeks' postmenstrual age.
Measured: 12-24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start1 Aug 2024
- Primary completion28 Mar 2026 (estimated)
- Study completion28 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Very Low Birth Weight InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHRISTUS Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pratik K Parikh, MD, Principal investigator, CHRISTUS HealthRichelle L Homo, MD, Principal investigator, CHRISTUS Health; Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555315
- Sponsor's protocol ID
- 2024-091
- Status last verified
- Aug 2024
- First submitted
- 31 Jul 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sriranjan J, Kalata C, Fusch G, Thomas K, Goswami I. Prevalence and Implications of Low Reticulocyte-Hemoglobin Levels among Extreme Preterm Neonates: A Single-Center Retrospective Study. Nutrients. 2022 Dec 16;14(24):5343. doi: 10.3390/nu14245343.
PubMed 36558502Wang Y, Wu Y, Li T, Wang X, Zhu C. Iron Metabolism and Brain Development in Premature Infants. Front Physiol. 2019 Apr 25;10:463. doi: 10.3389/fphys.2019.00463. eCollection 2019.
PubMed 31105583McCarthy EK, Dempsey EM, Kiely ME. Iron supplementation in preterm and low-birth-weight infants: a systematic review of intervention studies. Nutr Rev. 2019 Dec 1;77(12):865-877. doi: 10.1093/nutrit/nuz051.
PubMed 31532494Nii M, Okamoto T, Sugiyama T, Aoyama A, Nagaya K. Reticulocyte hemoglobin content changes after treatment of anemia of prematurity. Pediatr Int. 2022 Jan;64(1):e15330. doi: 10.1111/ped.15330.
PubMed 36321339Puia-Dumitrescu M, Tanaka DT, Spears TG, Daniel CJ, Kumar KR, Athavale K, Juul SE, Smith PB. Patterns of phlebotomy blood loss and transfusions in extremely low birth weight infants. J Perinatol. 2019 Dec;39(12):1670-1675. doi: 10.1038/s41372-019-0515-6. Epub 2019 Oct 3.
PubMed 31582812Bahr TM, Tan S, Smith E, Beauman SS, Schibler KR, Grisby CA, Lowe JR, Bell EF, Laptook AR, Shankaran S, Carlton DP, Rau C, Baserga MC, Flibotte J, Zaterka-Baxter K, Walsh MC, Das A, Christensen RD, Ohls RK; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Serum ferritin values in neonates <29 weeks' gestation are highly variable and do not correlate with reticulocyte hemoglobin content. J Perinatol. 2023 Nov;43(11):1368-1373. doi: 10.1038/s41372-023-01751-z. Epub 2023 Aug 18.
PubMed 37596391Karakoc G, Orgul G, Sahin D, Yucel A. Is every other day iron supplementation effective for the treatment of the iron deficiency anemia in pregnancy? J Matern Fetal Neonatal Med. 2022 Mar;35(5):832-836. doi: 10.1080/14767058.2021.1910666. Epub 2021 Apr 18.
PubMed 33866933Stoffel NU, Zeder C, Brittenham GM, Moretti D, Zimmermann MB. Iron absorption from supplements is greater with alternate day than with consecutive day dosing in iron-deficient anemic women. Haematologica. 2020 May;105(5):1232-1239. doi: 10.3324/haematol.2019.220830. Epub 2019 Aug 14.
PubMed 31413088von Siebenthal HK, Gessler S, Vallelian F, Steinwendner J, Kuenzi UM, Moretti D, Zimmermann MB, Stoffel NU. Alternate day versus consecutive day oral iron supplementation in iron-depleted women: a randomized double-blind placebo-controlled study. EClinicalMedicine. 2023 Nov 3;65:102286. doi: 10.1016/j.eclinm.2023.102286. eCollection 2023 Nov.
PubMed 38021373Pasupathy E, Kandasamy R, Thomas K, Basheer A. Alternate day versus daily oral iron for treatment of iron deficiency anemia: a randomized controlled trial. Sci Rep. 2023 Feb 1;13(1):1818. doi: 10.1038/s41598-023-29034-9.
PubMed 36725875German KR, Comstock BA, Parikh P, Whittington D, Mayock DE, Heagerty PJ, Bahr TM, Juul SE. Do Extremely Low Gestational Age Neonates Regulate Iron Absorption via Hepcidin? J Pediatr. 2022 Feb;241:62-67.e1. doi: 10.1016/j.jpeds.2021.09.059. Epub 2021 Oct 7.
PubMed 34626672Uyoga MA, Mikulic N, Paganini D, Mwasi E, Stoffel NU, Zeder C, Karanja S, Zimmermann MB. The effect of iron dosing schedules on plasma hepcidin and iron absorption in Kenyan infants. Am J Clin Nutr. 2020 Oct 1;112(4):1132-1141. doi: 10.1093/ajcn/nqaa174.
PubMed 32678434Manapurath RM, Gadapani Pathak B, Sinha B, Upadhyay RP, Choudhary TS, Chandola TR, Mazumdar S, Taneja S, Bhandari N, Chowdhury R. Enteral Iron Supplementation in Preterm or Low Birth Weight Infants: A Systematic Review and Meta-analysis. Pediatrics. 2022 Aug 1;150(Suppl 1):e2022057092I. doi: 10.1542/peds.2022-057092I.
PubMed 35921671MacQueen BC, Baer VL, Scott DM, Ling CY, O'Brien EA, Boyer C, Henry E, Fleming RE, Christensen RD. Iron Supplements for Infants at Risk for Iron Deficiency. Glob Pediatr Health. 2017 Apr 25;4:2333794X17703836. doi: 10.1177/2333794X17703836. eCollection 2017.
PubMed 28491927
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Non-inferiority Study Investigating Daily Versus Every Other Day Dosing of Oral Iron in Premature Infants.
- ClinicalTrials.gov ID
- NCT06555315
- Acronym / sponsor ID
- 2024-091
- Conditions
- Very Low Birth Weight Infant, Premature Infants, Anemia of Prematurity, Iron Deficiency, Anaemia in Children, Extremely Low Birth Weight
- Keywords
- Premature infants, Iron, anemia of prematurity, iron deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CHRISTUS HealthUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 28 Mar 2026 (estimated)
- Study completion
- 28 Mar 2026 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study focuses on determining if daily versus every-other-day (EOD) oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks post-menstrual age in premature neonates
Detailed description
Iron is an important component of hemoglobin, and an essential part of erythropoiesis. It is also a necessary micronutrient for rapidly proliferating and differentiating cells and tissues especially in the brain. Iron deficiency in infancy has been associated with anemia and impaired neurodevelopmental outcomes that extend into childhood. Premature infants are at highest risk for iron deficiency because they are deprived of the iron accretion that occurs in the third trimester of pregnancy, are born with lower iron stores compared to their term counterparts, and have increased utilization and depletion of iron stores with their rapid growth rate.
In older populations, EOD iron supplementation is as effective as daily iron supplementation in the treatment of iron deficiency anemia, with studies revealing significantly fewer gastrointestinal side effects in those who are on EOD iron. Adults regulate their iron status through a feedback pathway involving hepcidin whereby iron-sufficient individuals will have upregulated hepcidin, which leads to decreased iron absorption and availability. Recent studies have revealed that pediatric patients and premature neonates regulate iron absorption through hepcidin in a similar fashion. Though the regulation of iron status through hepcidin has been studied in extremely premature neonates, the clinical effect of EOD dosing of iron has not yet been examined in this population.
This is a non-inferiority, blinded, randomized control trial designed to investigate if EOD iron is comparable to daily iron dosing in achieving iron replete status by reticulocyte hemoglobin measurements in premature infants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Dietary Supplement: 6 mg/kg of oral iron as ferrous sulfate administered every day.After the infant achieves full enteral feeds, the infant is started on 6 mg/kg of oral iron daily supplementation. The dose of 6 mg/kg of enteral iron was chosen based on the aforementioned recommendations with evidence of its safety, while minimizing the need to increase the enteral iron dosage if an infant were to be started on ESAs where a dose of 6 mg/kg of enteral iron supplementation is the standard practice. Phlebotomy to obtain a complete blood count, reticulocyte count, and reticulocyte hemoglobin count is pursued the Monday after starting iron supplementation and every 2 weeks thereafter to weeks to monitor hematocrit or hemoglobin levels and iron status. |
| Intervention Group | Experimental | Dietary Supplement: 6 mg/kg of oral iron as ferrous sulfate administered every other day.After the infant achieves full enteral feeds, the infant is started on 6mg/kg of oral iron supplementation administered every other day. The dose of 6 mg/kg of enteral iron was chosen based on the aforementioned recommendations with evidence of its safety, while minimizing the need to increase the enteral iron dosage if an infant were to be started on ESAs where a dose of 6 mg/kg of enteral iron supplementation is the standard practice. Phlebotomy to obtain a complete blood count, reticulocyte count, and reticulocyte hemoglobin count is pursued the Monday after starting iron supplementation and every 2 weeks thereafter to weeks to monitor hematocrit or hemoglobin levels and iron status. |
Who may qualify
- Ages
- 26 to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children (Minor < 18 years of age)
- Neonates
- Hospitalized
- Premature infants who are on full enteral feeds and are started on oral iron
- Premature infants who completed 26 0/7 to 32 6/7 weeks' gestation at birth
Key exclusion criteria (1 listed)
- Infants with known congenital anomalies or chromosomal abnormalities (such as Trisomy 18 or Trisomy 21), conditions that affect iron metabolism (such as thalassemia or hemochromatosis), bleeding disorders or coagulopathy, and received iron parenterally prior to randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6 mg/kg of oral iron as ferrous sulfate administered every other day.6mg/kg of oral iron as ferrous sulfate administered every other day instead of 6 mg/kg of oral iron daily supplementation. | Dietary supplement | Intervention Group |
| 6 mg/kg of oral iron as ferrous sulfate administered every day.6 mg/kg of oral iron as daily ferrous sulfate instead of 6mg/kg of oral iron supplementation administered every other day. | Dietary supplement | Control Group |
Primary outcome
Determine if daily versus EOD oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks PMA.
Time frame: 1 Week-36 Weeks
The iron replete status will be measured by reticulocyte hemoglobin (Ret-Hb) between EOD and daily iron supplementation.
6 secondary outcomes
Characterize Ret-Hb levels in preterm infants.
Time frame: 12-24 Months
Identify the number of blood transfusions received between enrollment and 36 weeks' PMA between two groups.
Time frame: 12-24 Months
Determine prevalence of bronchopulmonary dysplasia between two groups.
Time frame: 12-24 Months
Identify the number of subjects with sepsis between two groups.
Time frame: 12-24 Months
Identify the number with necrotizing enterocolitis (NEC)/gastrointestinal perforations between two groups.
Time frame: 12-24 Months
Characterize growth between two groups.
Time frame: 12-24 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Results publication: PubMed 36558502Sriranjan J, Kalata C, Fusch G, Thomas K, Goswami I. Prevalence and Implications of Low Reticulocyte-Hemoglobin Levels among Extreme Preterm Neonates: A Single-Center Retrospective Study. Nutrients. 2022 Dec 16;14(24):5343. doi: 10.3390/nu14245343.
- Results publication: PubMed 31105583Wang Y, Wu Y, Li T, Wang X, Zhu C. Iron Metabolism and Brain Development in Premature Infants. Front Physiol. 2019 Apr 25;10:463. doi: 10.3389/fphys.2019.00463. eCollection 2019.
- Results publication: PubMed 31532494McCarthy EK, Dempsey EM, Kiely ME. Iron supplementation in preterm and low-birth-weight infants: a systematic review of intervention studies. Nutr Rev. 2019 Dec 1;77(12):865-877. doi: 10.1093/nutrit/nuz051.
- Results publication: PubMed 36321339Nii M, Okamoto T, Sugiyama T, Aoyama A, Nagaya K. Reticulocyte hemoglobin content changes after treatment of anemia of prematurity. Pediatr Int. 2022 Jan;64(1):e15330. doi: 10.1111/ped.15330.
- Results publication: PubMed 31582812Puia-Dumitrescu M, Tanaka DT, Spears TG, Daniel CJ, Kumar KR, Athavale K, Juul SE, Smith PB. Patterns of phlebotomy blood loss and transfusions in extremely low birth weight infants. J Perinatol. 2019 Dec;39(12):1670-1675. doi: 10.1038/s41372-019-0515-6. Epub 2019 Oct 3.
- Results publication: PubMed 37596391Bahr TM, Tan S, Smith E, Beauman SS, Schibler KR, Grisby CA, Lowe JR, Bell EF, Laptook AR, Shankaran S, Carlton DP, Rau C, Baserga MC, Flibotte J, Zaterka-Baxter K, Walsh MC, Das A, Christensen RD, Ohls RK; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Serum ferritin values in neonates <29 weeks' gestation are highly variable and do not correlate with reticulocyte hemoglobin content. J Perinatol. 2023 Nov;43(11):1368-1373. doi: 10.1038/s41372-023-01751-z. Epub 2023 Aug 18.
- Results publication: PubMed 33866933Karakoc G, Orgul G, Sahin D, Yucel A. Is every other day iron supplementation effective for the treatment of the iron deficiency anemia in pregnancy? J Matern Fetal Neonatal Med. 2022 Mar;35(5):832-836. doi: 10.1080/14767058.2021.1910666. Epub 2021 Apr 18.
- Results publication: PubMed 31413088Stoffel NU, Zeder C, Brittenham GM, Moretti D, Zimmermann MB. Iron absorption from supplements is greater with alternate day than with consecutive day dosing in iron-deficient anemic women. Haematologica. 2020 May;105(5):1232-1239. doi: 10.3324/haematol.2019.220830. Epub 2019 Aug 14.
- Results publication: PubMed 38021373von Siebenthal HK, Gessler S, Vallelian F, Steinwendner J, Kuenzi UM, Moretti D, Zimmermann MB, Stoffel NU. Alternate day versus consecutive day oral iron supplementation in iron-depleted women: a randomized double-blind placebo-controlled study. EClinicalMedicine. 2023 Nov 3;65:102286. doi: 10.1016/j.eclinm.2023.102286. eCollection 2023 Nov.
- Results publication: PubMed 36725875Pasupathy E, Kandasamy R, Thomas K, Basheer A. Alternate day versus daily oral iron for treatment of iron deficiency anemia: a randomized controlled trial. Sci Rep. 2023 Feb 1;13(1):1818. doi: 10.1038/s41598-023-29034-9.
- Results publication: PubMed 34626672German KR, Comstock BA, Parikh P, Whittington D, Mayock DE, Heagerty PJ, Bahr TM, Juul SE. Do Extremely Low Gestational Age Neonates Regulate Iron Absorption via Hepcidin? J Pediatr. 2022 Feb;241:62-67.e1. doi: 10.1016/j.jpeds.2021.09.059. Epub 2021 Oct 7.
- Results publication: PubMed 32678434Uyoga MA, Mikulic N, Paganini D, Mwasi E, Stoffel NU, Zeder C, Karanja S, Zimmermann MB. The effect of iron dosing schedules on plasma hepcidin and iron absorption in Kenyan infants. Am J Clin Nutr. 2020 Oct 1;112(4):1132-1141. doi: 10.1093/ajcn/nqaa174.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pratik K Parikh, MD principal investigator
CHRISTUS Health
Richelle L Homo, MD principal investigator
CHRISTUS Health; Brooke Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 mg/kg of oral iron as ferrous sulfate administered every other day. and 6 mg/kg of oral iron as ferrous sulfate administered every day. in people with Very Low Birth Weight Infant and Premature Infants, run by CHRISTUS Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosario Ocampo (210-704-4996, rosario.ocampo@christushealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if daily versus EOD oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks PMA. (time frame: 1 Week-36 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06555315, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.